Implications of bone metastasis on response to systemic therapy in patients with advanced renal cell carcinoma: A systematic literature review.

INTRODUCTION: Bone metastases negatively affect prognosis in patients with advanced renal cell carcinoma (aRCC). We conducted a systematic literature review to identify clinical trial publications including patients with aRCC with and without bone metastases. METHODS: The review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta­Analyses (PRISMA) guidelines and registered with PROSPERO (CRD42022355436). MEDLINE and Embase databases were searched (September 2, 2022) to identify publications reporting efficacy and safety outcomes for patients with/without bone metastasis from clinical trials of systemic RCC therapies. Risk of bias was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Of 526 publications screened, 19 were eligible: seven (from five studies) reported phase 3 trials, six reported phase 2 trials, one reported phase 1b/2 trials, and five were pooled analyses. Five publications reported moderate-quality evidence, while 14 were graded as low- or very low-quality evidence, suggesting a high potential for uncertainty. Five studies reported benefits of investigational therapies versus comparators in patients with and without bone metastases; these studies included cabozantinib, nivolumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab treatment arms. Data were also available for nivolumab plus ipilimumab. Bone metastases were consistently associated with poor prognosis in patients with aRCC. Preliminary data support the hypothesis that therapies targeting pathways implicated in the development of bone metastases may be beneficial, and warrant further investigation. However, data to support treatment decision-making are lacking. CONCLUSION: Our findings highlight the need for clinical data to assist in defining the optimal treatment for patients with aRCC and bone metastasis.

ACcurate COnsensus Reporting Document (ACCORD) explanation and elaboration: Guidance and examples to support reporting consensus methods.

BACKGROUND: When research evidence is limited, inconsistent, or absent, healthcare decisions and policies need to be based on consensus amongst interested stakeholders. In these processes, the knowledge, experience, and expertise of health professionals, researchers, policymakers, and the public are systematically collected and synthesised to reach agreed clinical recommendations and/or priorities. However, despite the influence of consensus exercises, the methods used to achieve agreement are often poorly reported. The ACCORD (ACcurate COnsensus Reporting Document) guideline was developed to help report any consensus methods used in biomedical research, regardless of the health field, techniques used, or application. This explanatory document facilitates the use of the ACCORD checklist. METHODS AND FINDINGS: This paper was built collaboratively based on classic and contemporary literature on consensus methods and publications reporting their use. For each ACCORD checklist item, this explanation and elaboration document unpacks the pieces of information that should be reported and provides a rationale on why it is essential to describe them in detail. Furthermore, this document offers a glossary of terms used in consensus exercises to clarify the meaning of common terms used across consensus methods, to promote uniformity, and to support understanding for consumers who read consensus statements, position statements, or clinical practice guidelines. The items are followed by examples of reporting items from the ACCORD guideline, in text, tables and figures. CONCLUSIONS: The ACCORD materials - including the reporting guideline and this explanation and elaboration document - can be used by anyone reporting a consensus exercise used in the context of health research. As a reporting guideline, ACCORD helps researchers to be transparent about the materials, resources (both human and financial), and procedures used in their investigations so readers can judge the trustworthiness and applicability of their results/recommendations.

Self-monitoring blood pressure in Pregnancy: Evaluation of health professional experiences of the BUMP trials.

BACKGROUND: The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether they improved detection or control of hypertension for women at risk of hypertension or with hypertension during pregnancy. This process evaluation aimed to understand healthcare professionals' perspectives and experiences of the BUMP trials of self-monitoring of blood pressure during pregnancy. METHODS: Twenty-two in-depth qualitative interviews and an online survey with 328 healthcare professionals providing care for pregnant people in the BUMP trials were carried out across five maternity units in England. RESULTS: Analysis used Normalisation Process Theory to identify factors required for successful implementation and integration into routine practice. Healthcare professionals felt self-monitoring of blood pressure did not over-medicalise pregnancy for women with, or at risk of, hypertension. Most said self-monitored readings positively affected their clinical encounters and professional roles, provided additive information on which to base decisions and enriched their relationships with pregnant people. Self-monitoring of blood pressure shifts responsibilities. Some healthcare professionals felt women having responsibility to decide on timing of monitoring and whether to act on self-monitored readings was unduly burdensome, and resulted in healthcare professionals taking additional responsibility for supporting them. CONCLUSIONS: Despite healthcare professionals' early concerns that self-monitoring of blood pressure might over-medicalise pregnancy, our analysis shows the opposite was the case when used in the care of pregnant people with, or at higher risk of, hypertension. While professionals retained ultimate clinical responsibility, they viewed self-monitoring of blood pressure as a means of sharing responsibility and empowering women to understand their bodies, to make judgements and decisions, and to contribute to their care.

Costs of management of acute respiratory infections in older adults: A systematic review and meta-analysis.

Background: Acute respiratory infections (ARIs) accounted for an estimated 3.9 million deaths worldwide in 2015, of which 56% occurred in adults aged 60 years or older. We aimed to identify the cost of ARI management in older adults (≥50 years) in order to develop an evidence base to assist decision-making for resource allocation and inform clinical practice. Methods: We searched 8 electronic databases including Global Health, Medline and EMBASE for studies published between January 1, 2000 and December 31, 2021. Total management costs per patient per ARI episode were extracted and meta-analysis was conducted by World Health Organization (WHO) region and World Bank income level. All costs were converted and inflated to Euros (€) (2021 average exchange rate). The quality of included studies and the potential risk of bias were evaluated. Results: A total of 42 publications were identified for inclusion, reporting cost data for 8 082 752 ARI episodes in older adults across 20 countries from 2001 to 2021. The majority (86%) of studies involved high-income countries based in Europe, North America and Western Pacific. The mean cost per episode was €17 803.9 for inpatient management and €128.9 for outpatient management. Compared with costs reported for patients aged <65 years, inpatient costs were €154.1, €7 018.8 and €8 295.6 higher for patients aged 65-74 years, 75-84 years and over 85 years. ARI management of at-risk patients with comorbid conditions and patients requiring higher level of care, incurred substantially higher costs for hospitalization: €735.9 and €1317.3 respectively. Conclusions: ARIs impose a substantial economic burden on health systems, governments, patients and societies. This study identified high ARI management costs in older adults, reinforcing calls for investment by global health players to quantify and address the scale of the challenge. There are large gaps in data availability from low-income countries, especially from South East Asia and Africa regions.

Self-monitoring of blood pressure in pregnancy: A mixed methods evaluation of a national roll-out in the context of a pandemic.

OBJECTIVE: To evaluate how English maternity units implemented self-monitoring of blood pressure (SMBP) in pregnancy in response to the COVID-19 pandemic. DESIGN: Mixed methods including surveys, anonymised patient data and in-depth interviews with women. SETTING: Maternity units across England. PARTICIPANTS: 45 maternity units completed a survey about the implementation of SMBP (supported by the provision of guidance and blood pressure monitors) during the pandemic, 166 women completed a survey about their experiences of SMBP, and 23 women took part in in-depth interviews. Clinical data from 627 women undertaking SMBP were available from 13 maternity units. RESULTS: SMBP was predominantly used to provide additional BP monitoring for hypertensive or high-risk pregnant women. Overall maternity units and women were positive about its use in terms of reducing the need for additional face-to-face contacts and giving women more control and insight into their own BP. However, there were challenges in setting up SMBP services rapidly and embedding them within existing care pathways, particularly around interpreting readings and managing the provision of monitors. CONCLUSIONS: A considerable proportion of maternity units in England commenced a SMBP service for hypertensive or high-risk women from March 2020. There is a need for further research into appropriate care pathways, including guidance around white coat or masked hypertension and the use of SMBP postnatally.

Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

"You Probably Won't Notice Any Symptoms": Blood Pressure in Pregnancy-Discourses of Contested Expertise in an Era of Self-Care and Responsibilization.

Pregnancy is not a disease or illness, but requires clinical surveillance as life-threatening complications can develop. Preeclampsia, one such potentially serious complication, puts both mother and baby at risk. Self-monitoring blood pressure in the general population is well established, and its potential in pregnancy is currently being explored. In the context of self-monitoring, the information and guidance given to women regarding hypertension, and the literature they themselves seek out during pregnancy, are vital to perceptions of disease risk and subsequent responses to, and management of, any symptoms. Drawing on online, offline, official, and unofficial sources of information, discourses are examined to provide analysis of how self-responsibilization is reflected in contemporary information, advice, and guidance drawn from multiple sources. A paradox emerges between the paternalistic and lay discourses that seek to challenge and regain control. Findings are discussed in the context of Foucault's governmentality and medical power.

Wild data: how front-line hospital staff make sense of patients' experiences.

Patient-centred care has become the touchstone of healthcare policy in developed healthcare systems. The ensuing commodification of patients' experiences has resulted in a mass of data but little sense of whether and how such data are used. We sought to understand how front-line staff use patient experience data for quality improvement in the National Health Service (NHS). We conducted a 12-month ethnographic case study evaluation of improvement projects in six NHS hospitals in England in 2016-2017. Drawing on the sociology of everyday life, we show how front-line staff worked with a notion of data as interpersonal and embodied. In addition to consulting organisationally sanctioned forms of data, staff used their own embodied interactions with patients, carers, other staff and the ward environment to shape improvements. The data staff found useful involved face-to-face interaction and dialogue; were visual, emotive, and allowed for immediate action. We draw on de Certeau to re-conceptualise this as 'wild data'. We conclude that patient experience data are relational, and have material, social and affective dimensions, which have been elided in the literature to date. Practice-based theories of the everyday help to envision 'patient experience' not as a disembodied tool of managerialism but as an embedded part of healthcare staff professionalism.

Opportunities to diagnose fibrotic lung diseases in routine care: A primary care cohort study.

BACKGROUND AND OBJECTIVE: Temporal trends of healthcare use in the period before a diagnosis of pulmonary fibrosis are poorly understood. We investigated trends in respiratory symptoms and LR HRU in the 10 years prior to diagnosis. METHODS: We analysed a primary care clinical cohort database (UK OPCRD) and assessed patients aged ≥40 years who had an electronically coded diagnosis of pulmonary fibrosis between 2005 and 2015 and a minimum 2 years of continuous medical records prior to diagnosis. Exclusion criteria consisted of electronic codes for recognized causes of pulmonary fibrosis such as CTD, sarcoidosis or EAA. RESULTS: Data for 2223 patients were assessed. Over the 10 years prior to diagnosis of pulmonary fibrosis, there was a progressive increase in HRU across multiple LR-related domains. Five years before diagnosis, 18% of patients had multiple healthcare contacts for LR complaints; this increased to 79% in the year before diagnosis, with 38% of patients having five or more healthcare contacts. CONCLUSION: There are opportunities to diagnose pulmonary fibrosis at an earlier stage; research into case-finding algorithms and strategies to educate primary care physicians is required.

'Team capital' in quality improvement teams: findings from an ethnographic study of front-line quality improvement in the NHS.

BACKGROUND: Teamwork is important in the design and delivery of initiatives in complex healthcare systems but the specifics of quality improvement (QI) teams are not well studied. OBJECTIVE: To explain the functioning of front-line healthcare teams working on patient-centred QI using Bourdieu's sociological construct of capital. METHODS: One medical ward from each of six NHS Trusts in England participated in the study, purposively selected for a range of performance levels on patient experience metrics. Three ethnographers conducted focused ethnography for 1 year, using interviews and observations to explore the organisation, management and delivery of patient-centred QI projects by the six front-line teams. Data were analysed using Bourdieu's typology of the four forms of capital: economic, social, symbolic and cultural. RESULTS: While all teams implemented some QI activities to improve patient experience, progress was greater where teams included staff from a broad range of disciplines and levels of seniority. Teams containing both clinical and non-clinical staff, including staff on lower grades such as healthcare assistants and clerks, engaged more confidently with patient experience data than unidisciplinary teams, and implemented a more ambitious set of projects. We explain these findings in terms of 'team capital'. CONCLUSION: Teams that chose to restrict membership to particular disciplines appeared to limit their capital, whereas more varied teams were able to draw on multiple resources, skills, networks and alliances to overcome challenges. Staff of varying levels of seniority also shared and valued a broader range of insights into patient experience, including informal knowledge from daily practice. The construct of 'team capital' has the potential to enrich understanding of the mechanism of teamwork in QI work.

How do frontline staff use patient experience data for service improvement? Findings from an ethnographic case study evaluation.

OBJECTIVES: Improving patient experience is widely regarded as a key component of health care quality. However, while a considerable amount of data are collected about patient experience, there are concerns this information is not always used to improve care. This study explored whether and how frontline staff use patient experience data for service improvement. METHODS: We conducted a year-long ethnographic case study evaluation, including 299 hours of observations and 95 interviews, of how frontline staff in six medical wards at different hospital sites in the United Kingdom used patient experience data for improvement. RESULTS: In every site, staff undertook quality improvement projects using a range of data sources. Teams of health care practitioners and ancillary staff engaged collectively in a process of sense-making using formal and informal sources of patient experience data. While survey data were popular, 'soft' intelligence - such as patients' stories, informal comments and observations - also informed staff's improvement plans, without always being recognized as data. Teams with staff from different professional backgrounds and grades tended to make more progress than less diverse teams, being able to draw on a wider net of practical, organizational and social resources, support and skills, which we describe as team-based capital. CONCLUSIONS: Organizational recognition, or rejection, of specific forms of patient experience intelligence as 'data' affects whether staff feel the data are actionable. Teams combining a diverse range of staff generated higher levels of 'team-based capital' for quality improvement than those adopting a single disciplinary approach. This may be a key mechanism for achieving person-centred improvement in health care.

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.

The Relationship Between Real-World Inhaled Corticosteroid Adherence and Asthma Outcomes: A Multilevel Approach.

BACKGROUND: Low inhaled corticosteroid (ICS) adherence is associated with increased asthma burden. This relationship is likely bidirectional, and may vary across adherence stages (initiation, implementation, and persistence). Studies rarely examine reciprocal influences. OBJECTIVE: To investigate the relationship between ICS implementation and asthma-related outcomes over 2 years, considering bidirectionality and temporal sequence. METHODS: Primary care records (1987-2012) from the Optimum Patient Care Research Database, United Kingdom, were used. Eligible patients were 6 years or older and had 3 or more years of continuous registration starting 1 year before ICS initiation (index date), physician-diagnosed asthma, 2 or more ICS and/or short-acting ß-agonist prescriptions each follow-up year, and no long-acting ß-agonists, leukotriene receptor antagonists, or maintenance oral corticosteroids in the preceding year. ICS implementation (percentage of days covered) and risk domain asthma control (RDAC; no asthma-related hospitalizations, emergency visits, or outpatient visits and no oral corticosteroid or antibiotic prescriptions with evidence of respiratory review) were estimated for each prescription interval (period between 2 successive prescriptions). Multilevel analyses modeled bidirectional relationships between ICS implementation and RDAC (and its components), controlling for sociodemographic and clinical characteristics. RESULTS: In prescription data from 10,472 patients, ICS implementation in the preceding interval did not predict RDAC, but was weakly positively associated with simultaneous RDAC. Being male, non-current smoker, without chronic obstructive pulmonary disease diagnosis, and with fewer than 4 comorbidities significantly increased odds of RDAC. Asthma-related antibiotics and outpatient visits in the same interval and short-acting ß-agonist overuse in the preceding and same interval predicted lower ICS implementation. CONCLUSIONS: Patients may adapt their ICS use to their current needs without this impacting later RDAC.

Prevalence and Characteristics of Asthma-Chronic Obstructive Pulmonary Disease Overlap in Routine Primary Care Practices.

Rationale: Adults may exhibit characteristics of both asthma and chronic obstructive pulmonary disease (COPD), a situation recently described as asthma-COPD overlap (ACO). There is a paucity of information about ACO in primary care.Objectives: To estimate the prevalence and describe characteristics of individuals with ACO in primary care practices among patients currently diagnosed with asthma, COPD, or both; and to compare the prevalence and characteristics of ACO among the three source populations.Methods: The Respiratory Effectiveness Group conducted a cross-sectional study of individuals ≥40 years old and with ≥2 outpatient primary care visits over a 2-year period in the UK Optimum Patient Care Research Database. Patients were classified into one of three source populations based on diagnostic codes: 1) COPD only, 2) both asthma and COPD, or 3) asthma only. ACO was defined as the presence of all of the following 1) age ≥40 years, 2) current or former smoking, 3) post-bronchodilator airflow limitation (forced expiratory volume in 1 second/forced vital capacity <0.7), and 4) ≥12% and ≥200 ml reversibility in post-bronchodilator forced expiratory volume in 1 second.Results: Among 2,165 individuals (1,015 COPD only, 395 with both asthma and COPD, and 755 asthma only), the overall prevalence of ACO was 20% (95% confidence interval, 18-23%). Patients with ACO had a mean age of 70 years (standard deviation, 11 yr), 60% were men, 73% were former smokers (the rest were current smokers), and 66% were overweight or obese. Comorbid conditions were common in patients with ACO, including diabetes (53%), cardiovascular disease (36%), hypertension (30%), eczema (23%), and rhinitis (21%). The prevalence of ACO was higher in patients with a diagnosis of both asthma and COPD (32%) compared with a diagnosis of COPD only (20%; P < 0.001) or asthma only (14%; P < 0.001). Demographic and clinical characteristics of ACO varied across these three source populations.Conclusions: One in five individuals with a diagnosis of COPD, asthma, or both asthma and COPD in primary care settings have ACO based on the Respiratory Effectiveness Group ACO Working group criteria. The prevalence and characteristics of patients with ACO varies across the three source populations.

Quality standards in respiratory real-life effectiveness research: the REal Life EVidence AssessmeNt Tool (RELEVANT): report from the Respiratory Effectiveness Group-European Academy of Allergy and Clinical Immunology Task Force.

INTRODUCTION: A Task Force was commissioned jointly by the European Academy of Allergy and Clinical Immunology (EAACI) and the Respiratory Effectiveness Group (REG) to develop a quality assessment tool for real-life observational research to identify high-quality real-life asthma studies that could be considered within future guideline development. METHODS: The resulting REal Life EVidence AssessmeNt Tool (RELEVANT) was achieved through an extensive analysis of existing initiatives in this area. The first version was piloted among 9 raters across 6 articles; the revised, interim, version underwent extensive testing by 22 reviewers from the EAACI membership and REG collaborator group, leading to further revisions and tool finalisation. RELEVANT was validated through an analysis of real-life effectiveness studies identified via systematic review of Medline and Embase databases and relating to topics for which real-life studies may offer valuable evidence complementary to that from randomised controlled trials. The topics were selected through a vote among Task Force members and related to the influence of adherence, smoking, inhaler device and particle size on asthma treatment effectiveness. RESULTS: Although highlighting a general lack of high-quality real-life effectiveness observational research on these clinically important topics, the analysis provided insights into how identified observational studies might inform asthma guidelines developers and clinicians. Overall, RELEVANT appeared reliable and easy to use by expert reviewers. CONCLUSIONS: Using such quality appraisal tools is mandatory to assess whether specific observational real-life effectiveness studies can be used to inform guideline development and/or decision-making in clinical practice.

The REal Life EVidence AssessmeNt Tool (RELEVANT): development of a novel quality assurance asset to rate observational comparative effectiveness research studies.

BACKGROUND: Evidence from observational comparative effectiveness research (CER) is ranked below that from randomized controlled trials in traditional evidence hierarchies. However, asthma observational CER studies represent an important complementary evidence source answering different research questions and are particularly valuable in guiding clinical decision making in real-life patient and practice settings. Tools are required to assist in quality appraisal of observational CER to enable identification of and confidence in high-quality CER evidence to inform guideline development. METHODS: The REal Life EVidence AssessmeNt Tool (RELEVANT) was developed through a step-wise approach. We conducted an iterative refinement of the tool based on Task Force member expertise and feedback from pilot testing the tool until reaching adequate inter-rater agreement percentages. Two distinct pilots were conducted-the first involving six members of the Respiratory Effectiveness Group (REG) and European Academy of Allergy and Clinical Immunology (EAACI) joint Task Force for quality appraisal of observational asthma CER; the second involving 22 members of REG and EAACI membership. The final tool consists of 21 quality sub-items distributed across seven methodology domains: Background, Design, Measures, Analysis, Results, Discussion/Interpretation, and Conflict of Interest. Eleven of these sub-items are considered critical and named "primary sub-items". RESULTS: Following the second pilot, RELEVANT showed inter-rater agreement ≥ 70% for 94% of all primary and 93% for all secondary sub-items tested across three rater groups. For observational CER to be classified as sufficiently high quality for future guideline consideration, all RELEVANT primary sub-items must be fulfilled. The ten secondary sub-items further qualify the relative strengths and weaknesses of the published CER evidence. RELEVANT could also be applicable to general quality appraisal of observational CER across other medical specialties. CONCLUSIONS: RELEVANT is the first quality checklist to assist in the appraisal of published observational CER developed through iterative feedback derived from pilot implementation and inter-rater agreement evaluation. Developed for a REG-EAACI Task Force quality appraisal of recent asthma CER, RELEVANT also has wider utility to support appraisal of CER literature in general (including pre-publication). It may also assist in manuscript development and in educating relevant stakeholders about key quality markers in observational CER.

The characterisation of interstitial lung disease multidisciplinary team meetings: a global study.

Multidisciplinary team (MDT) diagnosis of interstitial lung disease (ILD) has been proposed as a gold standard, but there are no formal recommendations for MDT process or composition and limited knowledge regarding prevalence in routine practice. We performed a systematic evaluation of ILD diagnostic practice across a range of healthcare settings around the world. Electronic questionnaires were distributed across all global regions via society and collaborators networks. Responses from 457 unique centres across 64 countries were included in the analysis. Of the 350 (76.6%) centres holding formal meetings, the majority held face-to-face MDT meetings (80%), for a minimum of 30 min (93%), and discussed diagnosis (96.9%) and patient management (94.9%) at the meetings. Compared with non-academic and academic non-ILD centres, ILD academic centres reported a higher ILD caseload, held more formal MDT meetings, and were more likely to include histopathology and rheumatology specialists in their diagnostic team. Of the centres holding MDT meetings, 5.5% routinely discussed all new cases at such meetings. An MDT approach to ILD diagnosis is consistently interpreted and widely implemented across a range of routine care settings around the world. This observation will inform future ILD diagnostic agreement studies and diagnostic pathway recommendations.

Matched cohort study of therapeutic strategies to prevent preschool wheezing/asthma attacks.

Background: An inhaled corticosteroid (ICS) or leukotriene receptor antagonist (LTRA) may prevent wheezing/asthma attacks in preschoolers with recurrent wheeze when added to short-acting ß-agonist (SABA). Objective: The aim of this historical matched cohort study was to assess the effectiveness of these treatments for preventing wheezing/asthma attacks. Methods: Electronic medical records from the Optimum Patient Care Research Database were used to characterize a UK preschool population (1-5 years old) with two or more episodes of wheezing during 1 baseline year before first prescription (index date) of ICS or LTRA, or repeat prescription of SABA. Children initiating ICS or LTRA on the index date were matched 1:4 to those prescribed only SABA for age, sex, year of index prescription, mean baseline SABA dose, baseline attacks, baseline antibiotic prescriptions, and eczema diagnosis. Wheezing/asthma attacks (defined as asthma-related emergency attendance, hospital admission, or acute oral corticosteroid prescription) during 1 outcome year were compared using conditional logistic regression. Results: Matched ICS and SABA cohorts included 990 and 3,960 children, respectively (61% male; mean [SD] age 3.2 [1.3] years), and matched LTRA and SABA cohorts included 259 and 1,036 children, respectively (65% male; mean [SD] age 2.6 [1.2] years). We observed no significant difference between matched cohorts in the odds of a wheezing/asthma attack: ICS vs SABA, OR (95% CI) 1.01 (0.85-1.19) and LTRA vs SABA, OR (95% CI) 1.28 (0.96-1.72). Conclusion: We found no evidence that initiation of ICS or LTRA therapy is associated with fewer attacks during 1 outcome year than SABA alone for a heterogeneous group of preschool children with recurrent wheeze in the real-life clinical setting.